KeriFlex 210-P20003Recalls & reported problems
Keri Medical SA · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640181160679), received between Apr 4, 2024 and Apr 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2024Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
A KERIFLEX REVISION WAS DONE DUE TO A BROKEN IMPLANT 1 YEAR AFTER SURGERY. THE SURGEON REPORTED A SMALL FRACTURE THAT OCCURRED WHILE REAMING THE MIDDLE PHALANX DURING PRIMARY SURGERY, BUT NO STABILIZATION WAS NEEDED AND THE FRACTURE HAS SINCE HEALED. THE PATIENT IS GENERALLY HEALTHY AND HAS NO BONE DISEASE. THE SURGEON INJECTED THE JOINT WITH STEROIDS SEVERAL MONTHS BEFORE THE REPLACEMENT. HE ALSO HAD TO PERFORM TENOLYSIS UNDER LOCAL ANAESTHETIC ON THIS FINGER IN (B)(6) 2023 FOR STIFFNESS. MOVEMENT IMPROVED, BUT THE PAIN NEVER IMPROVED. REVISION SURGERY TOOK PLACE ON MONDAY (B)(6) 2024 WITH REMOVAL OF THE DEVICE AND REPLACEMENT WITH A LARGER SIZE. (THE EVENT HAS BEEN RECORDED BY KERI MEDICAL SA ON 03/06/2024 AND OCCURED IN UK).
Patient problems: Implant Pain
MAUDE report 19041527 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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